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Clinical Trials of COVID-19 Therapeutics and Vaccines
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Candan Hizel Perry, Havva Ö. Kılgöz, Şükrü Tüzmen
Another vaccine candidate, the Gam-COVID-Vac (Sputnik V) is based on heterologous prime- boost vaccination with two nonreplicating human adenovirus vector serotypes, Ad26 and Ad5, both incorporating the full-length SARS-CoV-2 S protein [36]. The strategy of using two serotypes was to avoid preexisting immunity against Ad-vectors for the second immunization. Clinical assessment of the vaccine profile was carried out by an initial rAd26-S vaccine dose administered to healthy adults, followed by a second dose of rAd5-S on day 21. Initial validation showed good safety and strong immunogenicity in healthy adults. Interim results from the Phase III trial showed over 90% vaccine efficacy in healthy volunteers. The Sputnik V vaccine administration is authorized in 65 countries including Egypt, Albania, Zimbabwe, and Jordan [24].
Spread and Control of Microbes
Published in Jim Lynch, What Is Life and How Might It Be Sustained?, 2023
Many countries joined the race to develop a vaccine which became possible when the DNA profile of SARS-Cov-2 was released by the Chinese authorities. The first to get approval was the Pfizer-BioNTech vaccine on December 11, 2020. It delivers a tiny piece of genetic code (mRNA) from the SARS-CoV-2 virus to boost host cells in the body to make these produce the spike protein, stimulating an immune response if the body is infected with the virus. The Moderna vaccine is an mRNA vaccine like the Pfizer-BioNTech product; both need to be stored in a freezer and therefore they are more difficult to transport. The Oxford-Astra Zeneca uses an engineered but harmless adenovirus (like the common cold) from chimpanzees to carry the spike protein to cells. It is like the Johnson & Johnson vaccine, and both can be stored in a refrigerator. The Novavax vaccine as a protein adjuvant contains the spike protein of the virus itself formulated as a nanoparticle which does not cause disease. Sputnik is also an adenovirus. Conventional vaccines take about 10–15 years to bring to market. The mRNA vaccines could be produced within a week, one of the massive advantages of modern molecular biology and chemistry. Synthetic production means no virus is needed. Vials of DNA with the spike protein contained on a plasmid are produced at −150°C. The plasmids are then put into the bacterium Escherichia coli. The bacterium is grown in a fermenter; the bacteria are then broken open with enzymes to release the plasmids, and the DNA purified by filtration. A single vial can give 50 million doses. For the adenovirus vaccines, infected cells are grown in bioreactors and purified after 60 days.
(Developing) pharmaceutical solutions to COVID-19
Published in Peri J. Ballantyne, Kath Ryan, Living Pharmaceutical Lives, 2021
Peri J. Ballantyne, Kath Ryan, Paul Bissell
Around the globe, an unprecedented effort is being made to find a safe and effective vaccine that will neutralise the SARS CoV-2 virus. As of late October 2020, the Regulatory Affairs Professional Society (RAPS) COVID-19 vaccine tracker showed 7 SARS-2 vaccines in Phase 3 clinical trials, 2 at the Phase 2–3 stage, 3 at Phase 2, 10 at Phase 1–2, and many more at Phase 1 and preclinical stages (Craven, 2020b; Craven, 2020c; see also Steckelberg et al., 2020; WHO, 2020c). To date, two vaccines have been approved by the Russian Ministry of Health – the Sputnik V and the EpiVacCorona. Both were introduced to the market before the completion of Phase 3 clinical trials (Craven, 2020c). Experts have cautioned that the vaccine development process requires adequate time to assess for safety and efficacy (Craven, 2020b; Craven, 2020c, Callaway, 2020). Indeed, a tension has emerged, based on a global interest in and competition over vaccine development and distribution. On the one hand, there appears to be an unprecedented global effort to collaborate on vaccine development in the face of this pandemic, reflected in this statement from the WHO:Immunization currently prevents 2–3 million deaths every year from diseases like diphtheria, tetanus, pertussis, influenza and measles. There are now vaccines to prevent more than 20 life-threatening diseases, and work is ongoing at unprecedented speed to also make COVID-19 a vaccine-preventable disease. There are currently over 169 COVID-19 vaccine candidates under development, with 26 of these in the human trial phase. WHO is working in collaboration with scientists, business, and global health organizations through the ACT Accelerator to speed up the pandemic response. When a safe and effective vaccine is found, COVAX (led by WHO, GAVI and CEPI) will facilitate the equitable access and distribution of these vaccines to protect people in all countries. People most at risk will be prioritized.(WHO, n.d.-e)5
COVID-19 and vaccination: myths vs science
Published in Expert Review of Vaccines, 2022
Vivek P. Chavda, Yangmin Chen, Jayant Dave, Zhe-Sheng Chen, Subhash C. Chauhan, Murali M. Yallapu, Vladimir N. Uversky, Rajashri Bezbaruah, Sandip Patel, Vasso Apostolopoulos
The WHO granted three non-replicating viral vector vaccines, Ad26.COV2.S (by Johnson & Johnson), Vaxzevria (previously known as AstraZeneca; ChAdOx1-SARS-COV-2) and Covishield (produced by Serum Institute of India), under emergency use listing. Following immunization with Ad26.COV2.S, a combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, were observed very rarely in Europe and Canada [144]. However, as per a recent report Ad26.COV2.S, with a single dose, provided 52.9% protection against moderate to severe–critical COVID-19. Nevertheless, protection varied by variant; greater protection was noticed against severe COVID-19, medical intervention, and death than against other endpoints, which lasted for at least 6 months [139]. The Vaxzevria vaccine, along with common hypersensitivity and anaphylactic reactions, has been linked to anxiety disorders, coagulation disorders, capillary leak syndrome, and neurological events [145]. According to preliminary evidence from clinical trials in Russia, the most common side effects of another adenovirus-based COVID-19 vaccine, Sputnik V, are influenza-like symptoms and injection-site reactions. There are many replicating viral vector-based vaccines under the different stages of clinical development described elsewhere [146].
Adverse rare events to vaccines for COVID-19: From hypersensitivity reactions to thrombosis and thrombocytopenia
Published in International Reviews of Immunology, 2022
Natalija Novak, Leticia Tordesillas, Beatriz Cabanillas
Other vaccines for COVID-19 are under rolling review by EMA, that is the case of CVnCoV (developed by CureVac AG), NVX-CoV2373 (developed by Novavax CZ AS), and Sputnik V (Gam-COVID-Vac, developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology). CVnCoV is a mRNA vaccine, NVX-CoV2373 is a protein-based vaccine, and Sputnik V is a DNA vaccine [45–47]. These vaccines contain among their ingredients excipients that have been pointed out as possible triggers of adverse events in the mRNA and DNA vaccines described in this review. In that respect, CVnCoV vaccine contains a PEG-ylated lipid, Sputnik V is based on adenovirus vectors and NVX-CoV2373 contains polysorbate 80. Some of these vaccines, such as Sputnik V have already been administrated in some countries after approval issued by their national regulatory agencies. In the phase-III-clinical trial with Sputnik V, there were adverse events in the same proportion in the placebo and the vaccine group. Three deaths in the vaccine group and in the placebo group occurred, none of them were considered related to the vaccine administration [48]. As these vaccines start to be approved by international regulators and their use spreads, possible adverse events should be monitored, and their causality should be studied.
Inequitable COVID-19 vaccine distribution and the intellectual property rights prolong the pandemic
Published in Expert Review of Vaccines, 2022
Manufacturing and development of most of the approved SARS-CoV-2 vaccines have been supported with public funds. Operation Warp Speed (OWS), a USA federal government project, has provided over $12 billion in taxpayer funds to aid pharmaceutical companies’ efforts to produce vaccines. Specifically, the OWS provided $2.5 billion to Moderna to support the development of the vaccine [3]. Likewise, Pfizer received $1.95 billion in public funds to manufacture and distribute 100 million doses of their vaccine while Pfizer’s partner BioNTech received $445 million from the German government to accelerate the development of the vaccine. In addition to taxpayer investment in the funding of these vaccines in the USA and Europe, China has directly funded the vaccine development by supporting companies Sinovac and Sinopharm [4]. Likewise, Sputnik V was developed in a Russian state-run research institute, the Gamaleya Research Institute [4]. These vaccines could not have been produced so rapidly and effectively without billions of dollars ($) invested by public institutions around the world. Ironically, Moderna and Pfizer expect to earn over $60 billion in revenues over 2021 and 2022. Despite these already unprecedented profits, Pfizer increased vaccine prices from $18.30 to $23, and Moderna increased prices from $22.60 to $25.50. Due to the use of public funds in the development and manufacturing of COVID-19 vaccines, COVID-19 vaccine patents should be waived and the technology should be shared to ensure the generic production and equitable global distribution of vaccines.